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Role of Genomic Imprinting in Cancer Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882684
Recruitment Status : Unknown
Verified March 2019 by Bai Chunxue, Chinese Alliance Against Lung Cancer.
Recruitment status was:  Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
LiSen Imprinting Diagnostic Inc.
Information provided by (Responsible Party):
Bai Chunxue, Chinese Alliance Against Lung Cancer

Study Description
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Brief Summary:
The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.

Condition or disease Intervention/treatment
Early Diagnosis Cancer Biomarker Genomic Imprinting Diagnostic Test: In-situ imprinting detection

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Role of Genomic Imprinting in Cancer Diagnosis
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cancer patients
The patients receive the surgery according to the indication of surgery. The diagnosis is confirmed by pathology of removed tissue. The result of imprinting detection are used as cancer group.
 Diagnostic Test: In-situ imprinting detection
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.
Benign tumor and other disease patients
Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control.
 Diagnostic Test: In-situ imprinting detection
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of imprinting cancer early detection [ Time Frame: In the middle of the study, an average of 15 months ]
    Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer

  2. Specificity of imprinting cancer early detection [ Time Frame: In the middle of the study, an average of 15 months ]
    Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases


Secondary Outcome Measures :
  1. Comparison of the sensitivity of the imprinting detection versus cytopathology [ Time Frame: In the middle of the study, an average of 15 months ]
    Number of patients "declared positive" with the imprinting early detection versus patients "declared positive" with the cytopathology

  2. Comparison of the specificity of the imprinting detection versus cytopathology [ Time Frame: In the middle of the study, an average of 15 months ]
    Number of patients "declared negative" with the imprinting early detection versus patients "declared negative" with the cytopathology


Biospecimen Retention:   Samples With DNA
This study collects biopsies samples including but not limited to bronchoscopy biopsy, bronchial lavage fluid, fine needle aspiration, cystoscopy biopsy, urine samples, colonoscopy biopsy.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.
Criteria

Inclusion Criteria:

  • Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
  • Biopsy samples available.
  • Male or female patients aged ≥ 18 years.
  • Participants signed informed consent form.

Exclusion Criteria:

  • Age under 18 years.
  • Severe cardiovascular diseases.
  • Central nervous system diseases.
  • Mental disorder.
  • Pregnant.
  • Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882684


Contacts
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Contact: Chunxue Bai, MD 18621170011 bai.chunxue@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Chunxue Bai, MD    18621170011    bai.chunxue@zs-hospital.sh.cn   
Contact: Dawei Yang, MD    13564703813    yang_dw@hotmail.com   
Sponsors and Collaborators
Chinese Alliance Against Lung Cancer
LiSen Imprinting Diagnostic Inc.
More Information
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Publications:

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Responsible Party: Bai Chunxue, Chair, Chinese Alliance Against Lung Cancer
ClinicalTrials.gov Identifier: NCT03882684    
Other Study ID Numbers: CAALC-005-LiSen
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No